Brookwood Global's Online Training Course Brochure 2020

Brookwood Global’s on demand online clinical research training courses

Contents Introduction Our online training courses: Essential GCP for Sponsors GCP Refresher for Sponsors 1 – tallest buildings challenge GCP Refresher for Sponsors 2 – inspection challenge Essential GCP for Investigators GCP Refresher for Investigators 1 – tallest buildings challenge GCP Refresher for Investigators 2 – inspection challenge GCP for Clinical Data Management

PV for ALL Know PV PV for the Local Safety Contact and L-QPPV PV Refresher Essential Safety Reporting for the Investigator Site Non-interventional Studies, General Principles (Module 1) NIS, Practical Aspects (Module 2) NIS Essentials for Investigators The Principles of the General Data Protection Regulation (GDPR) GCP for Clinical Laboratories Learn & Refresh UK Clinical Trial Regulations

Visit www.brookwood-global.com for further details and to order online

GCP

CDM PV

NIS

GDPR

GCLP Regs

Brookwood Global has published books and newsletters in clinical research and related areas for over 30 years. Our books include reference texts as well as useful best-practice guides. The books are now available in electronic format that can be read on a variety of devices and computers. As a bespoke alternative, all of our e-books can be fully customized in your own colours bearing your corporate logo. In our own small way, we are helping to reduce climate change. To reduce our carbon footprint paper versions will only be produced for our popular indexed ICH GCP guidelines book. All other publications can be ordered as paper versions if bulk or customized copies are required.

Why buy our training courses? • Online, on demand. Do it anywhere! All that is needed is a strong continuous internet signal • Globally log in at any time 24/7, 365 days a year • Can be done using PC, Mac, laptop, iPad, iPhone and android devices • Tracking of user activity • Progress reporting by user and group • Certification for satisfactory completion • The training is personalized using the participant’s first name • Costs depend on the number of participants • Excellent packages for multiple users • Option to fix costs with a 2-year agreement or longer • Help in the event of problems • Valuable e-resources.

Key:

Our ICH GCP E6(R2) Investigator Site Training meets the minimum criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors. These courses have CPD awards from the Royal Colleges of Physicians of the United Kingdom and Semmelweis University, Hungary.

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TransCelerate

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All of our online training can be done on PCs, Macs, laptops, iPhones, iPads and android devices

Visit www.brookwood-global.com for further details and to order online

GCP

CDM PV

NIS

GDPR

GCLP Regs

• ONLINE TRAINING •

GCP

GCP

GCP

Essential GCP for Sponsors • Essential Good Clinical Practice for Sponsors Online Training. • Based on the sponsor responsibilities laid down in Section 5 of the ICH GCP E6(R2) guidelines as well as some of the investigator responsibilities that sponsors need to monitor. • Users can choose between a narrated or read-only (no sound) track. • The training is divided into key sections, each with interactions. • Quick 50-question test at the end of the training confirms knowledge. • Those who attain the 80% pass mark will receive certification. • Test answers can be reviewed and the test retaken. • Takes around 1 hour.

GCP Refresher for Sponsors 1 – tallest buildings challenge • An interactive quiz game to scale the highest buildings of the world – it adds fun and interest to GCP training. • Sponsor-specific questions cover a wide range of GCP topics based on ICH E6(R2). • 11 levels of slightly increasing difficulty. • 5 questions at each level – must get 4 correct to proceed (80%). • Feedback given for incorrect answers, with opportunity to review and repeat the level. • Compulsory ‘Did You Know?’ sections to enhance learning. • Takes around 45 minutes.

GCP Refresher for Sponsors 2 – inspection challenge • A fun way to learn and refresh GCP for all sponsor personnel needing GCP training. • Participants ‘meet’ five different GCP inspectors who each ask 10 questions on different topics. • Answer 8/10 questions correctly in order to progress to the next inspector meeting. • Once all inspectors have been visited, and enough questions answered correctly, the participant will be awarded certification. • In addition to the Q&As there are a number of ‘Did You Know?’ interactions to supplement knowledge. • Valuable e-books provided, including a Guide to Informed Consent, the ICH GCP E6(R2) guidelines and Essential GCP.

Visit www.brookwood-global.com for further details and to order online

GCP

CDM PV

NIS

GDPR

GCLP Regs

• ONLINE TRAINING •

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GCP

TransCelerate

TransCelerate

TransCelerate

Essential GCP for Investigators • Online training available in 14 languages: English, French, German, Italian, Polish, LatAm Spanish, Brazilian Portuguese, Chinese, Japanese, Russian, Turkish, Serbian, Czech and Hungarian. • Based on the investigator responsibilities laid down in Section 4 of the ICH GCP E6(R2) guidelines. • Users can choose between a narrated or read-only (no sound) track. • The training is divided into key sections, each with interactions. • Integral quizzes and an online multi- choice test at the end of the training confirms knowledge. • Those who attain the 80% pass mark receive certification. • Test answers can be reviewed and the test retaken. • Takes around 1 hour.

GCP Refresher for Investigators 1 – tallest buildings challenge • An interactive quiz game to scale the highest buildings of the world – it adds fun and interest to GCP training. • Investigator-specific questions cover a wide range of GCP topics based on ICH E6(R2). • 11 levels of slightly increasing difficulty – complete them all to pass. • 5 questions at each level – must get 4 correct to proceed (80%). • Feedback given for incorrect answers, with opportunity to review and repeat the level. • Compulsory ‘Did You Know?’ sections to enhance learning. • Takes around 45 minutes.

GCP Refresher for Investigators 2 – inspection challenge • A fun way to learn and refresh GCP for all investigator site personnel. • Participants ‘meet’ five different GCP inspectors who each ask 10 questions on different topics. • Answer 8/10 questions correctly in order to progress to the next inspector meeting. • Once all inspectors have been visited, the participant will be awarded certification. • In addition to the Q&As there are a number of ‘Did You Know?’ interactions to supplement knowledge. • Valuable resources provided, including a Guide to Informed Consent, the ICH GCP E6(R2) guidelines and Essential GCP. • Available in English and LatAm Spanish.

Visit www.brookwood-global.com for further details and to order online

GCP

CDM PV

NIS

GDPR

GCLP Regs

• ONLINE TRAINING •

CDM

PV

PV

GCP for Clinical Data Management

PV for ALL This 15 min* ‘Step 1’ online pharmacovigilance (PV) training is for an entire organization’s staff. It can be fully customized. Run it on your own server or let us manage it for you. Content includes: • Types of product safety information that may be encountered • Who might report safety information • How and when to report to the Local Safety Contact • Key information to be obtained.

Know PV This 60 min* ‘Step 2’ online training covers essential PV in more depth. It is ideal for those who need a more detailed knowledge of PV. Content includes: • What is and what governs PV • Roles and responsibilities • Key PV process steps; safety information and its capture • Product safety oversight • ADRs – basic facts, solicited v unsolicited reports • Expedited individual case safety reporting • MedDRA coding • Periodic safety reporting, PSURs, PBRERs, DSURs • Risk management planning • Safety signals • Reference safety information • PV system master file • Inspections.

This online on demand training with a quiz and certification is a fun interactive way for data management personnel to learn about their GCP responsibilities. Content includes: • Qualifications, training, SOPs • Computerized systems • Data flow and source data quality • Data collection, quality and management • Documentation • Using CROs • Risk register and risk-based approaches • GCP checklist for clinical data management.

* Average time taken. Individual timings will vary.

Visit www.brookwood-global.com for further details and to order online

GCP

CDM PV

NIS

GDPR

GCLP Regs

• ONLINE TRAINING •

PV

PV

PV

PV for the Local Safety Contact and L-QPPV

PV Refresher An interactive Q&A game to update and refresh PV knowledge. Face five inspectors and answer 8/10 questions correctly each time to ‘pass the inspection’! Questions include a wide range of PV topics.

Essential Safety Reporting for the Investigator Site

This 40 min* ‘Step 3’ online training covers the responsibilities of the company’s Local Safety Contact and the additional obligations of a Local QPPV (L-QPPV). Suitable for those involved as Local Safety Contacts and those who work with them. Content includes: • Regulatory requirements and main responsibilities • L-QPPV’s role in capturing, recording and reporting local safety information and PV activities • Managing local challenges.

This course is essential for all investigators needing to have awareness of their safety reporting obligations arising from the treatment of patients in clinical research. • Covers the basic principles of safety reporting, key regulations, guidance and best practices that apply to clinical trials and observational/non-interventional studies. • Consists of presented material, ‘Did You Know?’ highlights to supplement knowledge and numerous interactions to make the learning more enjoyable. • Has great resources including ICH E2A e-book, Essential Pharmacovigilance e-book, CIOMS form and CTCAE quick reference guide for causality assessment.

All of our online courses can be customized to meet your specific requirements. Let us run them for you using our full service package of registration, tracking, reporting and certification, or run them on your own learning management system.

* Average time taken. Individual timings will vary.

Visit www.brookwood-global.com for further details and to order online

GCP

CDM PV

NIS

GDPR

GCLP Regs

• ONLINE TRAINING •

NIS

NIS

NIS

Non-interventional Studies, General Principles (Module 1) Interactive, personalized, narrated and read- only tracks, suitable for both inexperienced and experienced staff. Provides a generic core basic training (takes approx. 35 mins). Content includes: • What are non-interventional studies (NIS)? • Why perform NIS? • Definition of NIS • Declaration of Helsinki • Rules governing NIS • Data protection • Requests by regulators • PAS, PASS, PAES explained • NIS in pharmacovigilance • Pharmacovigilance inspections • Abbreviations explained • Glossary of terms • Short quiz.

NIS, Practical Aspects (Module 2) Designed around an air journey to different parts of the real world to learn about key elements of running NIS. Content includes: • Setting up and running NIS • Planning • Impact of EU and US requirements • Choosing a design • Role of SCOPE; GRACE principles • Cross-sectional, case-control and cohort studies • Protocol content and development • Declaration of Helsinki and NIS • ENCePP guidance • Study milestones • Consent in NIS • Study conduct • Analysis of data • Codes of conduct and agreements • Scientific independence • Monitoring • MAH oversight obligations • NIS and safety reports; risk management plans • Data privacy • Study report • Publication of results • Training • Documentation and archives • Glossary of terms • Short quiz.

NIS Essentials for Investigators This training provides an understanding of the general obligations of researchers when undertaking NIS. Topics include: • Definition of non-interventional • Types of study • Key factors affecting NIS • Ethics and consent • Health authority approval • Data privacy • Protocol and its content • Current medical practice • Safety data collection • Study contracts • Data access • Study reports • Publication of results • Glossary of terms and abbreviations • Short quiz.

Visit www.brookwood-global.com for further details and to order online

GCP

CDM PV

NIS

GDPR

GCLP Regs

• ONLINE TRAINING •

GDPR

GCLP

Regs

The Principles of the General Data Protection Regulation (GDPR)

GCP for Clinical Laboratories – online training in GCLP This 30 min* narrated course is ideal for laboratory staff needing an insight into GCLP requirements, as well as sponsors’ monitors, medical experts and auditors who utilize laboratory services in clinical trials. It is based on the guidance given in the European Medicines Agency “Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples”, adopted by the GCP Inspectors Working Group in 2012. It covers the most important aspects in the Reflection Paper and offers practical advice on how and when a laboratory should comply. The program also covers some GCP basics to fulfil the requirement that laboratory staff have relevant GCP knowledge.

Learn & Refresh UK Clinical Trial Regulations This 60 min* course is designed for those who need to learn about and demonstrate their UK Clinical Trial Regulations knowledge. • Can be used as either initial or refresher training. • Take a journey through the regions of the UK and visit famous landmarks whilst you answer questions on the UK Clinical Trial Regulations. • Several ‘Did You Know?’ interactions enhance knowledge. • Visit nine locations and answer 8/10 questions correctly in each section to move on. • If you finish your tour satisfactorily you will be awarded certification.

This 30 min* online on demand training with a quiz and certification is an ideal way for those processing personal data to learn about the latest requirements for data protection. Content includes: • Key roles • Definitions of personal data • Applicability of the GDPR and exemptions • Consent and rights of Data Subjects • Legal basis for processing • Obligations towards Data Subjects • Risk assessment • Data transfer outside EEA • Record keeping • Data security and storage • The Data Protection Officer • Data protection ‘by design and default’ • Audits • Managing breaches, compensation and penalties • Data protection checklist • Specific content on the impact of GDPR on pharmacovigilance and clinical trials.

* Average time taken. Individual timings will vary.

Visit www.brookwood-global.com for further details and to order online

GCP

CDM PV

NIS

GDPR

GCLP Regs

For our full range of online courses, publications and face-to-face training visit

www.brookwood-global.com or contact us by phone or email info@brookwood-global.com

5 Studley Court Mews, Chobham, Surrey GU24 8EB, UK Tel: +44 1483 811383 Fax: +44 1483 812163

Email: info@brookwood-global.com Web: www.brookwood-global.com